NCT00512330

Brief Summary

In children, it remains quite difficult even in developed countries, to prove a diagnosis of Tuberculosis (TB). New means for diagnosis of this disease are currently being researched. One candidate test is Lipoarabinomannan ELISA from Urine, which has shown good sensitivity of up to 80% in adults. Our study aims to evaluate this test in the diagnosis of children with TB.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2007

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

August 6, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 7, 2007

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

August 6, 2008

Status Verified

August 1, 2008

First QC Date

August 6, 2007

Last Update Submit

August 5, 2008

Conditions

Tuberculosis

Keywords

childhoodtuberculosisdiagnosticlipoarabinomannanELISATuberculosis in Childhood

Eligibility Criteria

AgeUp to 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Study Population

Children up to 14 years of age with suspicion of TB

You may qualify if:

  • age 0-14 years
  • suspicion of active TB or TB contact

You may not qualify if:

  • no informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Our Lady of Mount Carmel Hospital

Kapiri/Mchinji, Mchinji, Malawi

RECRUITING

MeSH Terms

Conditions

TuberculosisDisease

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Norbert Heinrich, MD

    University of Bonn

    STUDY CHAIR

  • John Chimphamba, Clinical Officer

    Our Lady of Mount Carmel Hospital, Kapiri

    PRINCIPAL INVESTIGATOR

  • Andreas Mueller, PD Dr med.

    University of Bonn

    STUDY CHAIR

Central Study Contacts

Norbert Heinrich, MD

CONTACT

0049 179 7044231norbert.heinrich@ukb.uni-bonn.de

John Chimphamba, Clinical Officer

CONTACT

00265 9394287

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 6, 2007

First Posted

August 7, 2007

Study Start

August 1, 2007

Study Completion

August 1, 2008

Last Updated

August 6, 2008

Record last verified: 2008-08

Locations

MA(1)